24
Participants
Start Date
November 1, 2023
Primary Completion Date
August 31, 2026
Study Completion Date
August 31, 2031
Sentinel Lymph Node Biopsy (SLNB)
A sample of the participant's tumor-draining lymph nodes will be collected and sent to the biotherapy center for LNL isolation and expansion.
Doxorubicin
Doxorubicin will be administered at 60 mg/m\^2 IV on Day 1 of Cycles 1-2 of the neoadjuvant chemotherapy of the study.
Epirubicin
Epirubicin will be administered at 100 mg/m\^2 IV on Day 1 of Cycles 1-2 of the neoadjuvant chemotherapy of the study.
Cyclophosphamide
Cyclophosphamide will be administered at 600 mg/m\^2 IV on Day 1 of Cycles 1-2 of the neoadjuvant chemotherapy of the study.
Cyclophosphamide
Cyclophosphamide will be administered at 500 mg/m\^2 IV daily for three days. Cyclophosphamide will be initiated five days prior to the anticipated LNL transfer, and the precise timing will depend on the rate of in vitro LNL growth.
Fludarabine
Fludarabine will be administered at 30 mg/m\^2 IV daily for three days. Fludarabine will be initiated five days prior to the anticipated LNL transfer, and the precise timing will depend on the rate of in vitro LNL growth.
Tumor-draining lymph node-derived lymphocyte (LNL)
Participants receive single infusion of LNL at the recommended phase 2 dose (RP2D).
Interleukin-2
Eight to twelve hours after completing the LNL infusion, all participants will receive intermediate-dose decrescendo IL-2 IV.
Nab-paclitaxel
Nab-paclitaxel will be administered at 260 mg/m\^2 IV on Day 1 of Cycles 3-6 of the neoadjuvant chemotherapy of the study.
RECRUITING
Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
OTHER